Trans-sclera continuous administration device for eye disease treatment

Abstract

The utility model discloses a transsclera continuous administration device for eye disease treatment. The transsclera continuous administration device comprises an arc body, a wing-shaped fixing plate and a fixing band. A groove is formed in the bottom surface of the arc body; the two wing-shaped fixing plates are symmetrically arranged on the two sides of the arc body. The two wing-shaped fixing plates are respectively accommodated under the abdomen of the external rectus and under the abdomen of the lower rectus; the fixing belts are fixedly connected to the bottom face of the arc body, and gaps are formed between the fixing belts and the inner wall of the groove and used for storing medicine films; the ends, away from the arc body, of the two-wing-shaped fixing plates are spaced, and the arc body and the two-wing-shaped fixing plates are integrally in a C shape. The utility model discloses can fit the eyeball well, reduce the oppression to the eyeball, so as not influence the free rotation of eyeball, improve wearing comfort and drug bioavailability, reduce the medicine component exosmosis to the corneal conjunctival surface and fascia tissue, avoid the medicine passing through the conjunctival blood vessel and lymphatic vessel progress blood pressure circulation, reduce the risk of whole body side effect, improve the safety of eyeball. And toxicity and adverse reactions are reduced.

Description

TECHNICAL FIELD

[0001] The utility model relates to medical instrument technical field especially is related to a kind of transscleral sustained drug delivery device for eye disease treatment. BACKGROUND

[0002] At present, the main drug delivery routes of eye include ocular surface instillation, intravitreal injection, intravenous administration and transscleral drug delivery. However, due to the unique anatomical and physiological structure of eyeball and the existence of various biological barriers, such as corneal epithelial barrier, blood-aqueous barrier and blood-retinal barrier, the effective delivery of drugs into the eye faces many challenges. How to effectively deliver drugs to intraocular tissues to treat posterior segment diseases (such as age-related macular degeneration, retinal vascular disease, chronic uveitis and infectious endophthalmitis, etc.) has become a research hotspot in the field of ophthalmic disease treatment. The existence of corneal epithelial barrier and blood-aqueous barrier limits the ability of ocular surface instillation to reach effective therapeutic concentration in intraocular tissues, especially in posterior segment tissues. Although intravenous administration can deliver drugs to posterior segment tissues, the concentration of drugs in intraocular tissues is not enough to reach the effective therapeutic level due to the obstruction of blood-retinal barrier. At the same time, large-dose intravenous administration may lead to systemic drug toxicity and adverse reactions.

[0003] Intravitreal injection is currently recognized as one of the effective means for treating posterior segment diseases. Although this method can achieve high drug concentration in the eye in a short time, frequent injection may increase the risk of potential complications such as infectious endophthalmitis and retinal toxicity. Transscleral drug delivery route has become the research focus for exploring drug delivery to posterior segment tissues in recent years due to its high scleral drug permeability and safety advantages. However, how to deliver drugs to posterior segment target tissues at effective therapeutic concentration through transscleral route is still a key challenge in research.

[0004] Sclera accounts for five-sixths of the entire ocular surface area, and its main component is collagen fiber arranged uniformly and loosely. Therefore, compared with cornea, sclera has a larger drug absorption area and higher drug permeability, especially for hydrophilic drugs, it is easier to penetrate through the sclera. Many scholars at home and abroad have studied the permeability of sclera to different drugs, including betamethasone, oligonucleotide, albumin and anti-angiogenic factor drugs. Studies have shown that the absorption of drugs on the sclera is based on the steady-state flow of drugs through the sclera, which means that the drug must have sufficient contact with the surface of the sclera for a long time to achieve a steady-state flow. Transscleral drug delivery, also known as periocular drug delivery, includes subconjunctival injection, sub-Tenon's injection, retrobulbar and periocular injection. Compared with other drug delivery routes, transscleral drug delivery has the advantages of large drug absorption area, high drug permeability and small trauma. Compared with intraocular injection, transscleral drug delivery avoids the ocular disturbance caused by penetrating the eyeball, and also avoids the systemic side effects caused by intravenous injection. In addition, compared with eye drops, transscleral drug delivery does not need to be taken frequently, has more significant effect, and has higher patient compliance.

[0005] In the prior art, the research team based on previous research results applied for an invention patent with publication number CN117771163A, which discloses a drug for treating eye diseases and a sustained drug delivery device and a preparation method thereof. However, the use instruction of the sustained drug delivery device adopts succinic anhydride and pyridine to co-dissolve with triamcinolone acetonide to obtain a drug gel. The drug gel is released from the drug storage cavity of the drug delivery device. The drug gel has general stability. With the release of water in the drug gel, a semi-solid drug mass is easily formed, which is adsorbed in the inner part of the drug storage cavity and cannot be well attached to the surface of the sclera, thereby affecting the bioavailability of part of the drug. The drug gel is also easy to seep out to the ocular surface conjunctiva, which may increase the adverse reactions of the drug on the ocular surface tissue. In addition, the structure of the drug storage cavity of the drug delivery device is relatively large, which may cause a certain degree of compression to the eyeball. After the two wing-shaped fixed plates of the device are implanted under the extraocular muscles, the movement of the extraocular muscles may be affected due to the resistance of the device itself, so that the free rotation of the eyeball is limited.

[0006] Therefore, a transscleral sustained drug delivery device for treating eye diseases is provided. Content of the utility model

[0007] The utility model aims at providing a transscleral sustained drug delivery device for treating eye diseases, which aims at solving or improving at least one of the above technical problems.

[0008] To achieve the above-mentioned purpose, the utility model provides the following scheme: the utility model provides a transscleral sustained drug delivery device for treating eye diseases, comprising:

[0009] The top surface of the arc body is a smooth surface, and the bottom surface of the arc body is provided with a groove.

[0010] Two wing type fixing plates are symmetrically arranged on both sides of the arc body, and the two wing type fixing plates are respectively arranged below the muscle belly of the lateral rectus muscle and the inferior rectus muscle;

[0011] A plurality of fixing belts are fixed on the bottom surface of the arc body, and gaps are arranged between the fixing belts and the inner wall of the groove, and the gaps are used for storing medicine films.

[0012] The arc body, the two wing type fixing plates and the plurality of fixing belts are integrally formed, and the two wing type fixing plates are provided with intervals away from the arc body, and the arc body and the two wing type fixing plates are in a C shape as a whole.

[0013] The number of the fixing belts is two, the two fixing belts are symmetrically fixed on the bottom surface of the arc body, and intervals are arranged between the two fixing belts.

[0014] The length of the gap is 1.2mm-1.8mm.

[0015] The thickness of the arc body is 2.5mm-3.5mm.

[0016] The width of the arc body is 15mm-25mm.

[0017] The distance between the end of the wing type fixing plate away from the arc body and the top surface of the arc body is 40mm-60mm.

[0018] The cross-sectional shape of the wing type fixing plate is arc-shaped.

[0019] The utility model discloses the following technical effects:

[0020] The arc body and the two wing-shaped fixing plates are in a C shape as a whole, so that the device as a whole can be well attached to the eyeball and the compression on the eyeball is reduced, so that the free rotation of the eyeball is not affected, the wearing comfort and the drug bioavailability are improved, the drug film for treating eye diseases is stored in the gap, the drug is released from the drug film through passive diffusion and degradation, the release is more stable, more uniform and more persistent, the drug can be concentrated and attached to the selected sclera surface by using the drug film, the drug is fully penetrated into the intraocular tissue through the sclera surface, the drug components are reduced to exude on the conjunctiva and fascia tissue, the drug is prevented from circulating through the conjunctival blood vessels and lymphatic vessels, the risk of systemic side effects is reduced, the intraocular drug concentration during transscleral drug delivery is improved, and the drug bioavailability is improved. BRIEF DESCRIPTION OF DRAWINGS

[0021] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings needed to be used in the embodiments. Obviously, the drawings in the following description are only some embodiments of the present application, and for those skilled in the art, other drawings can also be obtained without creative labor.

[0022] Figure 1 is the front view of the present application; Figure I ;

[0023] Figure 2 is the front view of the present application; Figure II ;

[0024] Figure 3 is the front view of the present application;

[0025] Figure 4 is the top view of the present application.

[0026] 1, arc body; 2, groove; 3, wing-shaped fixing plate; 4, fixing belt. DETAILED DESCRIPTION

[0027] The technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only some embodiments of the present application, not all embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor are within the scope of protection of the present application.

[0028] In order to make the above-mentioned purposes, characteristics and advantages of the present application more obvious and easy to understand, the present application will be further described in detail below with reference to the drawings and specific embodiments.

[0029] Reference Figures 1-4The utility model provides a kind of for the treatment of ocular disease's transscleral sustained drug delivery device, comprising:

[0030] Arc body 1, the top surface of arc body 1 is smooth surface, and the bottom surface of arc body 1 is provided with groove 2;

[0031] Wing type fixed plate 3, two wing type fixed plates 3 are symmetrically arranged on the two sides of arc body 1, and the muscle belly under the lateral rectus muscle and the muscle belly under the inferior rectus muscle are respectively included in two wing type fixed plates 3;

[0032] Fixed band 4, several fixed bands 4 are provided, and the bottom surface of arc body 1 is fixedly connected with the inner wall of groove 2;The gap between the fixed band 4 and the inner wall of the groove 2 is used to store the drug film.

[0033] Among them, arc body 1, two wing type fixed plates 3 and several fixed bands 4 are integrally formed, one end of two wing type fixed plates 3 away from arc body 1 is provided with interval, and arc body 1 and two wing type fixed plates 3 are integrally formed as C-shaped;In the embodiment, the interval length between two wing type fixed plates 3 is 40mm~80mm.

[0034] In this way, the device is implanted into the Tenon's capsule under the eyeball through minimally invasive surgery, the top surface of arc body 1 is smooth surface, which is used to separate the direct contact between the drug film and the conjunctiva, reduce the absorption of the drug film through the conjunctival blood vessels and the removal and metabolism through the lymphatic vessels;The muscle belly under the lateral rectus muscle and the muscle belly under the inferior rectus muscle are respectively included in two wing type fixed plates 3, and the stability of the fixation is higher.

[0035] In the utility model, arc body 1 and two wing type fixed plates 3 are integrally formed as C-shaped, so that the device can be well fitted to the eyeball and reduce the pressure on the eyeball, thereby not affecting the free rotation of the eyeball, improving the wearing comfort and the drug bioavailability, the gap is used to store the drug film for the treatment of ocular disease, the drug is released from the drug film through passive diffusion and degradation, and the release is more stable, uniform and persistent, at the same time, the drug film can be used to make the drug concentrate and adhere to the selected sclera surface, so that the drug can fully penetrate the intraocular tissue through the sclera surface, reduce the exosmosis of the drug components on the corneal conjunctival surface and fascial tissue, avoid the further blood pressure circulation of the drug through the conjunctival blood vessels and lymphatic vessels, reduce the risk of systemic side effects, and also improve the intraocular drug concentration during transscleral drug delivery and improve the drug bioavailability.

[0036] Further optimization scheme, the number of fixed bands 4 is two, two fixed bands 4 are symmetrically fixedly connected on the bottom surface of arc body 1, and the interval between the two fixed bands 4 is provided;In the embodiment, the interval length between the two fixed bands 4 is 10mm~40mm.

[0037] Further optimization scheme, the length of the gap is 1.2mm~1.8mm, and in the embodiment, the length is preferably 1.5mm.

[0038] Further optimization scheme, the thickness of the circular arc body 1 is 2.5mm-3.5mm, and the preferred thickness in the embodiment is 3.0mm.

[0039] Further optimization scheme, the width of the circular arc body 1 is 15mm-25mm, and the preferred width in the embodiment is 20mm.

[0040] Further optimization scheme, the distance between the end of the airfoil-shaped fixing plate 3 away from the circular arc body 1 and the top surface of the circular arc body 1 is 40mm-60mm, and the preferred distance in the embodiment is 50mm, so that the overall length of the device is about 50mm.

[0041] Further optimization scheme, the cross-sectional shape of the airfoil-shaped fixing plate 3 is circular arc shape.

[0042] The utility model discloses still provide a kind of preparation method of transscleral sustained drug delivery device for eye disease treatment, comprising the following steps:

[0043] Step one, obtain the digital model of sustained drug delivery device;

[0044] Step two, sustained drug delivery device 3D model production: the virtual digital model is segmented into a series of continuous cross section, then the digital model is converted into 3D printer recognizable standard surface subdivision language (STL) file, and data is transmitted to 3D printer, using the characteristics that liquid photosensitive resin is quickly cured under ultraviolet laser beam irradiation, laser scanning printing is carried out in 3D printer using liquid photosensitive resin, and material is sprayed layer by layer, to make stereoscopic three-dimensional master mold;In the embodiment, 3D printer uses high-precision Liantai SLA printer, and liquid photosensitive resin uses GodartTM8228 resin;

[0045] Step three, sustained drug delivery device 3D model post-processing: the master mold on the printing platform is taken out, and alcohol is used to clean in ultrasonic cleaner to remove the uncured resin covered on the master mold;

[0046] Step four, the support structure on the master mold is removed using cutter, and lacquer art treatment is carried out on the surface of the master mold, and the curing of the master mold is completed after standing and drying;

[0047] Step five, using thermoplastic polyurethane elastomer material (TPU) to carry out remolding: thermoplastic polyurethane elastomer material DPI8400 A, B is mixed, stirred uniformly and then injected into the master mold obtained in step four, reacts for 45 minutes, and the soft gel hardness reaches 40A-50A after demolding and drying, to obtain the sustained drug delivery device that can be implanted under Tenon sac;

[0048] The utility model discloses adopt SLA light solidification forming technique mainly with liquid photosensitive resin as raw material, utilize the ultraviolet light of specific wavelength and intensity focus on liquid photosensitive resin surface, make it from point to line, from line to surface solidify in proper order, thereby complete a layer section's forming, compared with other 3D printing technology, SLA combines liquid photosensitive resin and has the significant advantages such as processing speed fast, forming precision high, surface finish high and material utilization rate high.

[0049] Thus, the sustained drug delivery device is made by 3D printing, and has the advantages of simple preparation process, low cost, good biocompatibility, good safety, high drug loading capacity, and controllable sustained drug delivery; the thermoplastic polyurethane elastomer material (TPU) is used for re-molding, and the thermoplastic polyurethane elastomer material (TPU) is an elastomer block polymer, which has a repeating urethane group functional group on the macromolecular backbone; compared with other 3D printing materials, the thermoplastic polyurethane elastomer material (TPU) has the significant advantage that the soft and hard segments are composed of different materials, so that the thermoplastic polyurethane elastomer material (TPU) has high elasticity of rubber and high strength of plastic; in addition, the thermoplastic polyurethane elastomer material (TPU) has excellent performance in wear resistance, drug resistance, antibacterial property, biomedical compatibility, shape memory performance, and is an elastomer material with excellent comprehensive performance, which is very suitable for manufacturing the new drug delivery device.

[0050] The thermoplastic polyurethane elastomer material DPI8400 used in the utility model has the advantages of low viscosity, good flowability, rapid curing and excellent elasticity, solves the problem that the liquid photosensitive resin material has slight toxicity and may cause allergy of the contact, and is not suitable for direct eyeball implantation; the hardness of the material can be controlled by adjusting the proportion of the components of DPI8400A and DPI8400B; in the utility model, the hardness of DPI8400 is adjusted to 40A-50A to reduce the size error caused by the shrinkage rate during the actualization of the model; at the same time, the TPU material with a hardness of 40A-50A has good softness, proper toughness and ductility, so that the drug delivery device after re-molding can better fit the eyeball, provide the function of sustained drug release, reduce the risk of tissue allergic reaction and local irritation, and reduce the occurrence of toxicity and adverse reactions.

[0051] In step two, the thickness of each layer of the sprayed material is 0.1 mm.

[0052] In step five, the re-molding is performed in an environment with a room temperature of 25 DEG C and a humidity of 60%-70%.

[0053] In step five, after demolding, the device is placed in a drying box for drying for 12 hours to obtain the sustained drug delivery device that can be implanted under the Tenon capsule.

[0054] The utility model discloses still provide a kind of drug membrane for the treatment of ocular disease, drug membrane is triamcinolone acetonide drug membrane;Triamcinolone acetonide drug membrane includes following component: acetone, triamcinolone acetonide, polycaprolactone, dichloromethane, polytetrafluoroethylene;The original drug gel is changed into drug membrane form in the utility model, can significantly improve the solubility and effective content of triamcinolone acetonide, triamcinolone acetonide is slowly released from drug membrane by passive diffusion and degradation, ensure that drug release process is more stable, uniform and persistent.

[0055] The utility model discloses still provide a kind of preparation method of drug membrane for the treatment of ocular disease, comprising the following steps:

[0056] S1:1.4g triamcinolone acetonide powder is dissolved in acetone, constant volume is 100ml, 14mg / ml TA solution is obtained;

[0057] S2:1.0g polycaprolactone is dissolved in dichloromethane, constant volume is 100ml, 10mg / ml PCL solution is obtained;

[0058] S3:the volume ratio of the mixture is 24:76 after mixing, and the theoretical drug loading of TA in the mixed solution reaches 30%;

[0059] S4:the mixed solution is evenly sprayed on polytetrafluoroethylene plate, and the sprayed drug membrane is placed in vacuum drying oven, and dried for 48h at room temperature, to form triamcinolone acetonide drug membrane, the drug for the treatment of ocular disease in the utility model is released from drug membrane by passive diffusion and degradation, and release is more stable, more uniform and more persistent.

[0060] Animal experiment process:

[0061] The animal experiment of the utility model is divided into two groups: the experimental group uses the dosing device of the utility model to carry triamcinolone acetonide drug membrane, and the control group uses subconjunctival injection. 48 New Zealand white rabbits are randomly divided into two groups, and 8 dosing time points are set in each group, and there are 3 rabbits under each time point.

[0062] The specific steps of the animal experiment of the experimental group are as follows:

[0063] 1. Anesthesia preparation:

[0064] Grab the rabbit, weigh the body weight, and inject intramuscularly with 0.3ml / kg dose of Lusonin, and test the corneal reflex of the rabbit to evaluate the depth of anesthesia.

[0065] During anesthesia, use levofloxacin eye drops to eye 3 times to prevent infection; use Aikeyin surface anesthetic to eye 3 times.

[0066] 2. Eye treatment:

[0067] After the rabbit is completely anesthetized, the eye is fully exposed using an eye speculum. The conjunctival sac is irrigated with 0.5 ml of anesthetized iodine using a syringe, and after standing for 30 seconds, the conjunctival sac is thoroughly rinsed with normal saline.

[0068] 3. Implanting the drug film:

[0069] An incision is made in the Tenon's capsule of the right eye of the rabbit, about 3 mm from the corneal limbus, and the space under the Tenon's capsule is exposed as much as possible. The lateral rectus muscle is carefully separated using blunt forceps.

[0070] The drug film is placed in the gap between the groove 2 structure and the fixing band 4 of the drug delivery device, the two wing-shaped fixing plates 3 of the drug delivery device are placed under the two rectus muscles, and the arc body 1 groove 2 structure of the device is stuffed into the Tenon's capsule, and the incision is sutured. This design facilitates minimally invasive implantation, and the device is small and portable. The two wing-shaped fixing plates 3 are implanted under the rectus muscles and are arc-shaped to fit the surface of the eyeball. In this way, the rectus muscles are used to fix the device, and the traction on the extraocular muscles is reduced. The groove structure closely fits the surface of the eyeball, allowing the drug film to maximize contact with the scleral surface, reducing drug extravasation to the corneal and conjunctival surface, thereby increasing the amount of drug attached to the scleral surface, prolonging the residence time of the drug on the scleral surface, reducing adverse reactions on the corneal and conjunctival surfaces and systemic side effects, reducing drug clearance and metabolism through conjunctival blood vessels and lymphatic vessels, and increasing drug penetration and effective concentration across the sclera.

[0071] 4. Anti-infection treatment:

[0072] Use levofloxacin eye drops for anti-infection, every 5 minutes, 3 times.

[0073] 5. Eye sampling:

[0074] Remove the right eyeball, cut off the muscles, conjunctiva and fascia on the surface of the eyeball, and fully expose the sclera of the eyeball.

[0075] Clean the surface of the eyeball with normal saline to remove residual liquid, and dry the eyeball with clean gauze.

[0076] 6. Collection of aqueous humor:

[0077] Use a 1 ml syringe to horizontally puncture the anterior chamber at 1.5 mm inside the corneal limbus, collect about 0.1-0.2 ml of aqueous humor, and store it at -80°C for determination of the concentration of triamcinolone acetonide in the aqueous humor.

[0078] 7. Collection of vitreous humor:

[0079] Clean the surface of the eyeball with normal saline to remove residual liquid, and dry the eyeball with clean gauze.

[0080] The sclera was cut open, and the vitreous humor was extracted into a 1.5 ml centrifuge tube using a 2.5 ml syringe, and stored at -80°C for determination of the concentration of triamcinolone in the vitreous body.

[0081] The specific process of the control group animal experiment is as follows:

[0082] 1. Anesthesia preparation:

[0083] The rabbit was caught, weighed, and then injected with Lusonine at a dose of 0.3 ml / kg by intramuscular injection, and the corneal reflex of the rabbit was tested to evaluate the depth of anesthesia.

[0084] 2. Eye treatment:

[0085] During the anesthesia process, levofloxacin eye drops were used to prevent infection, and Alkaein topical anesthetic was used 3 times.

[0086] 3. Conjunctival sac irrigation:

[0087] After the rabbit was completely anesthetized, the eye was fully exposed using a speculum. 0.5 ml of Anle I I I was used to irrigate the conjunctival sac using a syringe, and after 30 seconds, the conjunctival sac was thoroughly rinsed with normal saline.

[0088] 4. Drug injection:

[0089] 1 ml of triamcinolone injection solution was taken using a 1 ml syringe, and a subconjunctival injection was performed slowly in the right eye of the rabbit.

[0090] 5. Treatment of injection site:

[0091] After the injection was completed, the puncture site was closed with a toothless forceps for 30 seconds to ensure that the drug did not extravasate, and then the syringe was removed.

[0092] 6. Anti-infection treatment:

[0093] Levofloxacin eye drops were used for anti-infection, and eye drops were applied every 5 minutes for a total of 3 times.

[0094] 7. Eye sampling:

[0095] After the preset administration time point, the right eyeball was removed, and the muscles, conjunctiva and fascia on the surface of the eyeball were cut off to fully expose the sclera.

[0096] 8. Clean the eyeball:

[0097] The residual drug solution on the surface of the eyeball was removed with normal saline, and the eyeball was dried with clean gauze.

[0098] 9. Collection of aqueous humor:

[0099] The anterior chamber fluid was collected about 0.1-0.2ml at 1.5mm inside the corneal limbus with a 1ml syringe, and stored at -80℃ for determining the concentration of triamcinolone acetonide in the anterior chamber fluid.

[0100] 10. Cleaning the eyeball:

[0101] The residual liquid on the surface of the eyeball was removed with normal saline, and the eyeball was dried with clean gauze.

[0102] 11. Collection of vitreous humor:

[0103] The vitreous humor was extracted with a 2.5ml syringe to a 1.5ml centrifuge tube, and stored at -80℃ for determining the concentration of triamcinolone acetonide in the vitreous humor.

[0104] Experimental results:

[0105] It can be preliminarily concluded from the following charts that the triamcinolone acetonide drug film can reach an effective therapeutic concentration in the aqueous humor and vitreous humor of the rabbit eye after being administered by the administration device, and can maintain a certain action time.

[0106] In the vitreous tissue, the drug concentration continued to rise from 1h to 6h after administration, and the TA concentration in the vitreous tissue reached a peak value of 2.440μg / mL at 6h; then it slowly decreased until 14d. The pharmacokinetic parameters of triamcinolone acetonide in the vitreous tissue of the two groups are shown in Table 1. Statistical analysis by SPSS20.0 showed that the overall comparison of triamcinolone acetonide concentrations between the two groups had statistical difference (repeated measurement ANOVA, F=9.378, p=0.011), and the change of triamcinolone acetonide concentration in the two groups conformed to normal distribution. Independent sample t test statistical analysis showed that the difference in triamcinolone acetonide concentration between the two groups at 1h (t=4.788, p=0.009), 3h (t=5.602, p=0.005), 6h (t=2.897, p=0.044) and 24h (t=8.346, p=0.001) had statistical significance. The detailed statistical analysis results are shown in Table 2.

[0107] Table 1 Pharmacokinetic parameters of triamcinolone acetonide in the vitreous tissue of the two groups

[0108]

[0109] Table 2 Statistical analysis results of triamcinolone acetonide concentration in the vitreous tissue of the two groups

[0110]

[0111] In the aqueous humor tissue, the triamcinolone acetonide drug film reaches an effective therapeutic concentration locally in the eye and maintains a certain action time, and the concentration is (0.548±0.346) μg / mL at 0.5h after injection, which is about 50 times the effective therapeutic concentration; then the concentration slowly increases, and reaches the peak concentration (0.763±0.337) μg / mL at 24h, which is about 70 times the effective therapeutic concentration; then the concentration slowly decreases, and the concentration is (0.023±0.017) μg / mL at 14d, which is about 2 times the effective therapeutic concentration. The pharmacokinetic parameters of the triamcinolone acetonide concentration in the aqueous humor tissue of the two groups are shown in Table 3. Statistical analysis by SPSS 20.0 shows that the overall comparison of the triamcinolone acetonide concentration of the two groups has statistical difference (repeated measurement variance analysis, F=18.567, p=0.001), the change of the triamcinolone acetonide concentration of the two groups conforms to the normal distribution, and the independent sample t test is used for statistical analysis, and the Mann-Whitney test is used for statistical analysis when the normal distribution is not met, and it is concluded that the triamcinolone acetonide concentration of the two groups has statistical significance at 0.5h (t=-3.654, p=0.022), 1h (t=-6.02, p=0.009), 3h (t=-2.941, p=0.042) and 48h (Z=-1.993, p=0.046), and the detailed statistical analysis results are shown in Table 4.

[0112] Table 3 Pharmacokinetic parameters of triamcinolone acetonide concentration in aqueous humor tissue of two groups

[0113]

[0114] Table 4 Statistical analysis results of triamcinolone acetonide concentration in aqueous humor tissue of two groups

[0115]

[0116] In the description of the utility model, it is understood that the terms "longitudinal", "transverse", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer" and the like indicate the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the utility model, and do not indicate or imply that the indicated device or element must have a particular orientation, be constructed and operated in a particular orientation, therefore it cannot be understood as a limitation of the utility model.

[0117] Obviously, the above embodiments of the present application are merely examples for clearly illustrating the present application, and are not intended to limit the implementation modes of the present application. For the ordinary skilled in the art, other different forms of changes or variations can be made on the basis of the above description. Here, it is not necessary and also impossible to exhaust all the implementation modes. Any modification, equivalent replacement and improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application claims.

Claims

1. A transscleral continuous drug delivery device for the treatment of eye diseases, characterized in that, include: The top surface of the arc body (1) is a smooth surface, and the bottom surface of the arc body (1) is provided with a groove (2); Two wing-shaped fixing plates (3) are provided, and the two wing-shaped fixing plates (3) are symmetrically arranged on both sides of the arc body (1); the two wing-shaped fixing plates (3) are respectively inserted under the belly of the lateral rectus muscle and under the belly of the inferior rectus muscle; A fixing strap (4) is provided, and a plurality of fixing straps (4) are fixed to the bottom surface of the arc body (1). A gap is provided between the fixing strap (4) and the inner wall of the groove (2), and the gap is used to store the medicine film. The arc body (1), the two airfoil fixing plates (3) and the several fixing straps (4) are integrally formed. The two airfoil fixing plates (3) are spaced apart at one end away from the arc body (1). The arc body (1) and the two airfoil fixing plates (3) are C-shaped as a whole.

2. The transscleral continuous drug delivery device for treating ocular diseases according to claim 1, characterized in that: The number of fixing straps (4) is two, and the two fixing straps (4) are symmetrically fixed to the bottom surface of the arc body (1), and there is a gap between the two fixing straps (4).

3. The transscleral continuous drug delivery device for treating ocular diseases according to claim 1, characterized in that: The length of the gap is 1.2mm to 1.8mm.

4. The transscleral continuous drug delivery device for treating eye diseases according to claim 1, characterized in that: The thickness of the arc body (1) is 2.5mm to 3.5mm.

5. The transscleral continuous drug delivery device for treating ocular diseases according to claim 1, characterized in that: The width of the arc (1) is 15mm to 25mm.

6. The transscleral continuous drug delivery device for treating ocular diseases according to claim 1, characterized in that: The distance between the end of the airfoil fixing plate (3) away from the arc body (1) and the top surface of the arc body (1) is 40mm to 60mm.

7. The transscleral continuous drug delivery device for treating ocular diseases according to claim 1, characterized in that: The cross-sectional shape of the airfoil fixing plate (3) is circular arc.

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